U.S. patent application number 12/461775 was filed with the patent office on 2010-08-19 for method and system for sealing percutaneous punctures.
Invention is credited to Christopher U. Cates, Douglas P. Killion, Robert M. Vidlund.
Application Number | 20100211000 12/461775 |
Document ID | / |
Family ID | 41137879 |
Filed Date | 2010-08-19 |
United States Patent
Application |
20100211000 |
Kind Code |
A1 |
Killion; Douglas P. ; et
al. |
August 19, 2010 |
Method and system for sealing percutaneous punctures
Abstract
A device for sealing a puncture in a patient includes a sealing
component including an elongate control member configured to pass
through a puncture in skin of a patient. The sealing component also
includes an expandable member disposed near a distal end of the
control member, and a tip releasably attached to the elongate
control member distal to the expandable member. The device also
includes a sealing material delivery component including a delivery
tube through which the control member of the sealing component is
configured to extend. The delivery tube is configured to deliver
sealing material through an opening in a distal end of the delivery
tube.
Inventors: |
Killion; Douglas P.; (Maple
Grove, MN) ; Vidlund; Robert M.; (Forest Lake,
MN) ; Cates; Christopher U.; (Atlanta, GA) |
Correspondence
Address: |
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER;LLP
901 NEW YORK AVENUE, NW
WASHINGTON
DC
20001-4413
US
|
Family ID: |
41137879 |
Appl. No.: |
12/461775 |
Filed: |
August 24, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61190085 |
Aug 26, 2008 |
|
|
|
61213407 |
Jun 4, 2009 |
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Current U.S.
Class: |
604/57 ;
606/213 |
Current CPC
Class: |
A61B 2017/00991
20130101; A61B 17/00491 20130101; A61B 2017/0065 20130101; A61B
90/39 20160201; A61B 2090/064 20160201; A61B 2017/00557 20130101;
A61B 2017/00495 20130101; A61B 2017/00654 20130101; A61B 2017/00004
20130101; A61B 2090/037 20160201; A61B 17/0057 20130101; A61B
2017/00672 20130101; A61B 2017/00778 20130101; A61B 2017/00022
20130101 |
Class at
Publication: |
604/57 ;
606/213 |
International
Class: |
A61M 31/00 20060101
A61M031/00; A61B 17/00 20060101 A61B017/00 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 20, 2009 |
US |
PCT/US09/54492 |
Claims
1. A device for sealing a puncture in a patient, the device
including: a sealing component including: an elongate control
member configured to pass through a puncture in skin of a patient,
an expandable member disposed near a distal end of the elongate
control member, and a tip releasably attached to the elongate
control member distal to the expandable member; and a sealing
material delivery component including: a delivery tube through
which the elongate control member of the sealing component is
configured to extend, the delivery tube being configured to deliver
sealing material through an opening in a distal end of the delivery
tube.
2. The device of claim 1, wherein the delivery tube includes a
first cavity configured to deliver a first sealing material to a
location near the puncture in the patient when the expandable
member in an expanded configuration abuts a surface defining a
distal opening of the puncture.
3. The device of claim 2, wherein the delivery tube includes a
second cavity, and the sealing component is configured to pass
through the second cavity.
4. The device of claim 3, wherein the sealing component is
configured to be removed from the second cavity in the delivery
tube so that a second sealing material may be delivered through the
second cavity to a location near the first sealing material in the
patient.
5. The device of claim 1, wherein the sealing component includes a
connector that is controllable to adjust the position of the
sealing component with respect to the delivery tube of the sealing
material delivery component.
6. The device of claim 1, wherein the elongate control member
includes a lumen configured to direct fluid to the expandable
member; and the tip is releasably attached to a distal end of a
wire disposed in the lumen of the elongate control member.
7. The device of claim 6, wherein the sealing component further
includes a sealing component coupling that connects to the wire and
a proximal end of the elongate control member.
8. The device of claim 7, further including a sealing material
delivery component coupling connected to the delivery tube and
adjustably connected to the sealing component coupling.
9. The device of claim 1, further including a guide sheath through
which the delivery tube and the elongate control member are
configured to extend.
10. The device of claim 9, further including a guide sheath
coupling that connects a hub of the guide sheath to the sealing
material delivery component, the guide sheath coupling being
controllable to adjust the position of the guide sheath hub with
respect to the sealing material delivery component.
11. The device of claim 9, wherein: the delivery tube includes a
first cavity configured to deliver a first sealing material to a
location near the puncture in the patient when the expandable
member in an expanded configuration abuts a surface defining a
distal opening of the puncture; and the guide sheath is configured
to deliver a second sealing material to a location near the first
sealing material in the patient when the sealing component and the
sealing material delivery component are withdrawn from the guide
sheath.
12. The device of claim 1, further including a securement hub
attachable to at least one of the delivery tube and a guide sheath
through which the delivery tube and the elongate control member are
configured to extend, the securement hub being placed against the
skin of the patient.
13. The device of claim 12, wherein the securement hub includes a
tube inserted into the patient and a luer fitting configured to
direct fluid out of the patient.
14. The device of claim 1, wherein: the expandable member of the
sealing component is a first expandable member; and the sealing
material delivery component further includes a second expandable
member attached to the delivery tube and configured to be expanded
when located inside the puncture so that an outer surface of the
second expandable member contacts at least one of an inner surface
of a guide sheath surrounding the delivery tube or body tissue.
15. The device of claim 1, wherein the sealing component further
includes an insert member disposed on the elongate control member
proximal to the expandable member.
16. The device of claim 15, wherein the delivery tube is configured
to deliver a first sealing material onto the insert member, the
insert member forming a cavity in the first sealing material when
the insert member is removed.
17. The device of claim 16, wherein the tip is configured to be
positioned in the cavity and released from the sealing
component.
18. The device of claim 16, wherein the insert member is configured
to be in an expanded configuration when the first sealing material
is delivered and in an nonexpanded configuration when removed from
the cavity.
19. The device of claim 15, wherein the first sealing material is
delivered to surround the distal end of the delivery tube to form a
second cavity in the first sealing material when the delivery tube
is removed; and the delivery tube or a guide sheath is configured
to deliver a second sealing material to the second cavity.
20. The device of claim 1, wherein the tip is bioabsorbable.
21. The device of claim 1, wherein the tip includes a main body and
at least one projection extending outward from the main body.
22. The device of claim 21, wherein the at least one projection
includes one of a barb, a ring formed integrally with the main
body, and a ring formed of a different material than the main
body.
23. The device of claim 1, wherein the tip includes at least one of
a suture, a disc, pliable material, an expandable material, and a
stretchable braid.
24. The device of claim 1, wherein the tip includes at least one of
a distal flange and a proximal flange.
25. The device of claim 1, wherein the tip is configured to be
inserted into and extend at least partially through a cavity in a
first sealing material delivered inside the patient through the
delivery tube.
26. The device of claim 25, wherein the tip is configured to abut a
surface of a second sealing material delivered inside the patient
through the delivery tube or a guide sheath.
27. The device of claim 1, wherein the sealing component further
includes a release mechanism configured to release the tip from the
elongate control member.
28. The device of claim 27, wherein the release mechanism is
configured to permit the tip from separating from the elongate
control member due to a tensile force.
29.-43. (canceled)
44. A method of sealing a puncture in a wall of a body cavity of a
patient, the method including: inserting a sealing component and a
sealing material delivery component through a puncture in a wall of
a body cavity of a patient, the sealing material delivery component
including a delivery tube, the sealing component being slidably
disposed in the delivery tube and including an elongate control
member; inserting an expandable member connected to the elongate
control member through the puncture into the body cavity; expanding
the expandable member when the expandable member is distal to a
distal end of the delivery tube and inserted in the body cavity;
moving the expandable member near a distal surface of the wall of
the body cavity; delivering sealing material through the distal end
of the delivery tube and into the puncture; inserting a tip
disposed on the elongate control member and distal to the
expandable member into the sealing material; and detaching the tip
from the elongate control member when the tip is in the sealing
material.
45. The method of claim 44, further including withdrawing the
elongate control member from the patient; wherein the tip is
inserted into the sealing material when the elongate control member
is at least partially withdrawn from the patient.
46. The method of claim 44, wherein the elongate control member is
moved proximally with respect to the sealing material delivery
component so that the tip is inserted into the sealing
material.
47. The method of claim 44, wherein the sealing material is
delivered to surround the elongate control member proximal to the
wall of the body cavity.
48. The method of claim 47, wherein the tip is inserted into a
cavity in the sealing material when the elongate control member is
removed from the sealing material.
49. The method of claim 44, wherein the sealing material is
delivered to surround an insert member on the elongate control
member disposed proximal to the wall of the body cavity and distal
to the distal end of the delivery tube.
50. The method of claim 49, further including removing the insert
member from the sealing material to form a cavity in the sealing
material.
51. The method of claim 50, wherein the elongate control member is
moved proximally with respect to the sealing material delivery
component to insert the tip in the sealing material and to remove
the insert member from the sealing member.
52. The method of claim 50, wherein the tip is detached from the
elongate control member when the tip is inserted into the cavity in
the sealing material.
53. The method of claim 50, wherein the insert member is
expandable, and the method further includes: expanding the insert
member before surrounding the insert member with the sealing
material; and collapsing the insert member before removing the
insert member from the sealing material to form the cavity.
54. The method of claim 50, wherein the sealing material is a first
sealing material, and the cavity is a first cavity; the first
sealing material is delivered to surround the distal end of the
delivery tube; and the method further includes: removing the
delivery tube from the first sealing material to form a second
cavity in the first sealing material; and delivering a second
sealing material to the second cavity.
55. The method of claim 54, wherein the second sealing material is
delivered using the delivery tube or a guide sheath.
56. The method of claim 44, wherein the tip is bioabsorbable.
57. The method of claim 44, wherein the tip includes a main body
and at least one projection extending outward from the main
body.
58. The method of claim 57, wherein the at least one projection
includes one of a barb, a ring formed integrally With the main
body, and a ring formed of a different material than the main
body.
59. The method of claim 44, wherein the tip includes at least one
of a suture, a disc, pliable material, an expandable material, and
a stretchable braid.
60. The method of claim 44, wherein the tip includes at least one
of a distal flange and a proximal flange.
61. The method of claim 44, wherein: the sealing material is a
first sealing material; the tip is inserted into and extends at
least partially through a cavity in the first sealing material; and
the tip abuts a surface of a second sealing material delivered
inside the puncture through the delivery tube or a guide
sheath.
62. The method of claim 44, wherein the tip is detached from the
elongate control member using a release mechanism.
63. The method of claim 44, further including applying a tensile
force to the tip to separate the tip from the elongate control
member.
64.-74. (canceled)
75. A sealing component for sealing a puncture in a patient, the
sealing component including: an elongate control member configured
to pass through a puncture in skin of a patient; an expandable
member disposed near a distal end of the elongate control member;
and a tip releasably attached to the elongate control member distal
to the expandable member.
76. The sealing component of claim 75, wherein: the elongate
control member includes a lumen configured to direct fluid to the
expandable member; and the tip is releasably attached to a distal
end of a wire disposed in the lumen of the elongate control
member.
77. The sealing component of claim 75, further including an insert
member disposed on the elongate control member proximal to the
expandable member.
78. The sealing component of claim 75, wherein the tip is
bioabsorbable.
79. The sealing component of claim 75, wherein the tip is
nonbioabsorbable.
80. The sealing component of claim 75, wherein: the tip includes a
main body and at least one projection extending outward from the
main body; and the at least one projection includes one of a barb,
a ring formed integrally with the main body, and a ring formed of a
different material than the main body.
81. The sealing component of claim 75, wherein the tip includes at
least one of a suture, a disc, pliable material, an expandable
material, and a stretchable braid.
82. A method of sealing a puncture in a wall of a body cavity of a
patient, the method including: inserting a sealing component and a
sealing material delivery component through a puncture in a wall of
a body cavity of a patient, the sealing material delivery component
including a delivery tube, the sealing component being slidably
disposed in the delivery tube and including an elongate control
member; inserting an expandable member releasably connected to the
elongate control member through the puncture into the body cavity;
expanding the expandable member when the expandable member is
distal to a distal end of the delivery tube and inserted in the
body cavity; moving the expandable member near a distal surface of
the wall of the body cavity; delivering a sealing material through
the distal end of the delivery tube and into the puncture;
collapsing the expandable member; inserting the collapsed
expandable member in a cavity formed in the sealing material;
expanding the expandable member in the cavity formed in the sealing
material; and detaching the expandable member in the expanded
configuration from the elongate control member when the expandable
member is in the sealing material.
83. The method of claim 82, wherein the collapsed expandable member
is inserted into the cavity by at least partially withdrawing the
elongate control member from the patient.
84. The method of claim 82, wherein the expandable member is
bioabsorbable.
85. The method of claim 82, wherein the sealing material is
delivered to surround the elongate control member proximal to the
wall of the body cavity.
Description
[0001] This application claims the benefit of priority from U.S.
Provisional Application No. 61/190,085, filed Aug. 26, 2008, U.S.
Provisional Application No. 61/213,407, filed Jun. 4, 2009, and PCT
Application No. PCT/US09/54492, filed Aug. 20, 2009, each of which
is herein incorporated by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present disclosure relates generally to a method and
system for sealing, and more particularly, to a method and system
for sealing percutaneous punctures.
BACKGROUND OF THE INVENTION
[0003] The invention relates generally to the sealing of punctures
for various medical procedures and more particularly to the sealing
of such punctures using, in certain embodiments, a multi-stage
sealing material ejected into the puncture.
[0004] Certain medical procedures require the percutaneous
puncturing of the body tissue of a patient to gain access to a
cavity in the body to perform a medical procedure. One example of
such a procedure is the puncturing of body tissue and a blood
vessel wall to gain access to the interior of the vascular system
of the patient. Such procedures that commonly require the
percutaneous puncturing of a blood vessel wall are balloon
angioplasty procedures, arteriography, venography, angiography and
other diagnostic procedures that use blood vessel catheterization.
Examples of other procedures requiring a puncture through body
tissue into a cavity include laparoscopic surgery and other
microscopic surgery techniques using a small incision.
[0005] In each of these procedures, it is necessary to close the
incision or puncture through the body tissue after the surgical
procedure. While there are a variety of prior art devices and
techniques for closing such punctures, one of the primary problems
associated with the prior art is ensuring a complete seal of the
puncture. The invention described herein provides an improvement
over the prior art by resolving this problem and other
problems.
SUMMARY OF THE INVENTION
[0006] In one aspect, the present disclosure is directed to a
device for sealing a puncture in a patient. The device includes a
sealing component including an elongate control member configured
to pass through a puncture in skin of a patient. The sealing
component also includes an expandable member disposed near a distal
end of the elongate control member, and a tip releasably attached
to the elongate control member distal to the expandable member. The
device also includes a sealing material delivery component
including a delivery tube through which the elongate control member
of the sealing component is configured to extend. The delivery tube
is configured to deliver sealing material through an opening in a
distal end of the delivery tube.
[0007] In another aspect, the present disclosure is directed to a
method of sealing a puncture in a wall of a body cavity of a
patient. The method includes inserting a sealing component and a
sealing material delivery component through a puncture in a wall of
a body cavity of a patient. The sealing material delivery component
includes a delivery tube, and the sealing component is slidably
disposed in the delivery tube and includes an elongate control
member. The method also includes inserting an expandable member
connected to the elongate control member through the puncture into
the body cavity, expanding the expandable member when the
expandable member is distal to a distal end of the delivery tube
and inserted in the body cavity, and moving the expandable member
near a distal surface of the wall of the body cavity. The method
further includes delivering a first sealing material through the
distal end of the delivery tube and into the puncture, withdrawing
the elongate control member from the patient, and delivering a
second sealing material proximal to the wall of the body cavity
after the elongate control member is withdrawn from the
patient.
[0008] In a further aspect, the present disclosure is directed to a
method of sealing a puncture in a wall of a body cavity of a
patient. The method includes inserting a sealing component and a
sealing material delivery component through a puncture in a wall of
a body cavity of a patient. The sealing material delivery component
includes a delivery tube, and the sealing component is slidably
disposed in the delivery tube and includes an elongate control
member. The method also includes inserting an expandable member
connected to the elongate control member through the puncture into
the body cavity, expanding the expandable member when the
expandable member is distal to a distal end of the delivery tube
and inserted in the body cavity, and moving the expandable member
near a distal surface of the wall of the body cavity. The method
further includes delivering sealing material through the distal end
of the delivery tube and into the puncture, inserting a tip
disposed on the elongate control member and distal to the
expandable member into the sealing material, and detaching the tip
from the elongate control member when the tip is in the sealing
material.
[0009] In yet another aspect, the present disclosure is directed to
a method of sealing a puncture in a wall of a body cavity of a
patient. The method includes inserting a sealing component and a
sealing material delivery component through a puncture in a wall of
a body cavity of a patient. The sealing material delivery component
includes a delivery tube, and the sealing component is slidably
disposed in the delivery tube and includes an elongate control
member. The method also includes inserting an expandable member on
the elongate control member through the puncture into the body
cavity, and expanding the expandable member when the expandable
member is distal to a distal end of the delivery tube and inserted
in the body cavity. The method further includes locating the wall
of the body cavity by retracting the sealing component with respect
to the patient until the expandable member in the expanded
configuration abuts a distal surface of the wall of the body
cavity, and delivering sealing material through the distal end of
the delivery tube and proximal to the wall of the body cavity.
[0010] In yet a further aspect, the present disclosure is directed
to a sealing component for sealing a puncture in a patient. The
sealing component includes an elongate control member configured to
pass through a puncture in skin of a patient, an expandable member
disposed near a distal end of the elongate control member, and a
tip releasably attached to the elongate control member distal to
the expandable member.
[0011] In yet another aspect, the present disclosure is directed to
a method of sealing a puncture in a wall of a body cavity of a
patient. The method includes inserting a sealing component and a
sealing material delivery component through a puncture in a wall of
a body cavity of a patient. The sealing material delivery component
includes a delivery tube, and the sealing component is slidably
disposed in the delivery tube and includes an elongate control
member. The method also includes inserting an expandable member
releasably connected to the elongate control member through the
puncture into the body cavity, expanding the expandable member when
the expandable member is distal to a distal end of the delivery
tube and inserted in the body cavity, and moving the expandable
member near a distal surface of the wall of the body cavity. The
method further includes delivering a sealing material through the
distal end of the delivery tube and into the puncture, collapsing
the expandable member, and inserting the collapsed expandable
member in a cavity formed in the sealing material. The method also
includes expanding the expandable member in the cavity formed in
the sealing material and detaching the expandable member in the
expanded configuration from the elongate control member when the
expandable member is in the sealing material.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a side view of an exemplary embodiment showing a
delivery component.
[0013] FIG. 2 is a side view of an exemplary embodiment showing a
temporary sealing component.
[0014] FIG. 3 illustrates an exemplary embodiment with the sealing
system assembled and inserted into a guide sheath protruding from a
blood vessel.
[0015] FIG. 4 illustrates an exemplary embodiment with the guide
sheath and the assembled sealing system in a retracted
position.
[0016] FIG. 5 illustrates an exemplary embodiment with the sealing
system delivering the first stage of sealing material into the
puncture.
[0017] FIG. 6 illustrates an exemplary embodiment with the
temporary sealing component being removed from the assembled
sealing system.
[0018] FIG. 7 illustrates an exemplary embodiment with the delivery
component delivering the second stage of sealing material into the
puncture.
[0019] FIG. 8 illustrates an exemplary embodiment with the guide
sheath remaining in tract during closure with sealing system
inserted.
[0020] FIG. 9 illustrates an exemplary embodiment with the guide
sheath up against tamponading member.
[0021] FIG. 10 illustrates an exemplary embodiment with guide
sheath retracted back from tamponading member.
[0022] FIG. 11 illustrates an exemplary embodiment with sealing
system retracted at a known tension and skin securement hub
attached to the guide sheath.
[0023] FIG. 12 illustrates an exemplary embodiment with skin
securement hub attached to a delivery tube.
[0024] FIG. 13 illustrates an exemplary embodiment with a delivery
tube retracted prior to delivery of a second stage of sealing
material.
[0025] FIG. 14 illustrates an exemplary embodiment delivering the
second stage sealing material through the guide sheath.
[0026] FIG. 15 illustrates an exemplary embodiment with an
expandable member attached to a delivery tube and positioned within
body tissue.
[0027] FIG. 16 illustrates an exemplary embodiment with an
expandable member attached to a delivery tube and positioned within
the guide sheath.
[0028] FIG. 17 illustrates an exemplary embodiment of a sealing
system delivering first stage sealing material to create a hollow
cavity for positioning a tip.
[0029] FIG. 18 illustrates an exemplary embodiment of a hollow
cavity created by a sealing system after first stage sealing
material is delivered.
[0030] FIG. 19 illustrates an exemplary embodiment of a tip and
second stage sealing material positioned within a hollow
cavity.
[0031] FIG. 20 illustrates an exemplary embodiment of a tip with
barbs secured to the sides of a body.
[0032] FIG. 21 illustrates an exemplary embodiment of a tip with
rings around a body.
[0033] FIG. 22 illustrates an exemplary embodiment of a tip with
independent rings around a body.
[0034] FIG. 23 illustrates an exemplary embodiment of a tip that is
expandable.
[0035] FIG. 24 illustrates an exemplary embodiment of a tip
constructed of a suture with a knot tied within a main body of the
suture.
[0036] FIG. 25 illustrates an exemplary embodiment of a tip
constructed of a suture with a knot tied within the main body with
a disc.
[0037] FIG. 26 illustrates an exemplary embodiment of a tip
constructed of a braid configuration.
[0038] FIG. 27 illustrates an exemplary embodiment of a tip
constructed of a semi-rigid body with a soft pliable end.
[0039] FIG. 28 illustrates an exemplary embodiment of a tip
positioned within first stage sealing material and second stage
sealing material.
[0040] FIG. 29 illustrates an exemplary embodiment of a tip
positioned within first stage sealing material.
[0041] FIG. 30 illustrates an exemplary embodiment of a tip
positioned in close proximity to a blood vessel wall.
[0042] FIG. 31 illustrates an exemplary embodiment of a tip in
contact with first stage sealing material and second stage sealing
material.
[0043] FIGS. 32-35 illustrate various exemplary embodiments of
mechanisms for releasably attaching a tip to a temporary sealing
component.
[0044] These figures and the following detailed description
disclose specific embodiments of the invention, however, it is to
be understood that the inventive concept is not limited thereto and
may be embodied in other forms.
DESCRIPTION OF THE EMBODIMENTS
[0045] Reference will now be made in detail to exemplary
embodiments of the invention, examples of which are illustrated in
the accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same
or like parts.
[0046] The systems disclosed herein can be used to close or seal
percutaneous punctures made through the body tissue of a patient to
gain access to a body cavity of a patient. Access through these
percutaneous punctures allows a physician to carry out various
procedures in or through the body cavity for examination, surgery,
treatment and the like. While not meant to be limiting, the systems
are illustrated being used to seal the percutaneous punctures made
to gain access to blood vessels in patients for various procedures.
It will be appreciated that the systems are applicable to other
procedures requiring sealing of a puncture through body tissue into
a cavity including laparoscopic surgery and other microscopic
surgery techniques using a small incision.
[0047] The terms proximal and distal are used herein to refer to
the relative positions of the components of the exemplary sealing
system 10. When used herein, proximal refers to a position
relatively closer to the exterior of the body or closer to the
surgeon using the sealing system 10. In contrast, distal refers to
a position relatively further away from the surgeon using the
sealing system 10 or closer to the interior of the body.
[0048] An exemplary embodiment of sealing system 10 is illustrated
being used to seal a percutaneous puncture PP seen in FIG. 3 made
through the skin SK, body tissue BT and the wall BVW of a blood
vessel BV as an incident to a medical procedure. Typically, the
blood vessel BV used is a femoral artery in the groin region with a
relatively large vessel passage or lumen BVL to facilitate locating
the blood vessel BV and permitting a sufficiently large puncture to
be made through the wall BVW thereof to carry out the procedure.
Medical procedures which are typically performed through such a
puncture are angioplasty and other procedures which pass a catheter
or other type of probe into and along the blood vessel lumen BVL.
When such a procedure is performed, an initial percutaneous
puncture PP with an appropriate needle is made from the patient's
skin SK through the tissue BT and the blood vessel wall BVW into
the blood vessel lumen BVL, and a guide wire is installed. The
needle is then removed leaving the guide wire in place and a
tapered introducer guide sheath GS is installed over the guide wire
to enlarge the puncture so as to permit easier access to the blood
vessel BV. The guide sheath GS serves to keep the passage open and
prevent further damage to the tissue BT and skin SK around the
passage during the medical procedure. The guide sheath GS, while
not required to be used in connection with the present invention,
assists in the installation of the sealing system 10 as will become
more apparent.
[0049] Referring to FIGS. 1 and 2, an exemplary embodiment of the
sealing system 10 is illustrated showing a temporary sealing
component 11 and a sealing material delivery component 12. The
connector 14 permits positioning of the temporary sealing component
11 relative to the sealing material delivery component 12 in one or
more defined positions relative to each other and allows one to
positively locate the temporary sealing component 11 and the
sealing material delivery component 12 when inserted into the
puncture PP. The temporary sealing component 11 typically may be
pre-assembled within the sealing material delivery component 12
during manufacture, creating the sealing system 10.
[0050] The sealing system 10 is inserted into the blood vessel
lumen BVL through the introducer guide sheath GS as seen in FIG. 3.
As described in greater detail below, an expandable tamponading
member 21 of temporary sealing component 11 is expanded. The
sealing system 10 and sheath GS are then retracted, and the
expandable tamponading member 21 of temporary sealing component 11
serves to temporarily seal the interior end of the puncture PP
opening into the blood vessel lumen BVL. While the temporary
sealing component 11 is in the proper retracted position for
sealing the puncture PP in the blood vessel BV, the sealing
material delivery component 12 is located in the puncture PP and
proximate to the punctured blood vessel wall BVW, as seen in FIG.
4. When the sealing material delivery component 12 is located
proximate to the punctured blood vessel wall BVW, the first stage
67 of the sealing material for sealing the puncture PP is injected
through the sealing material delivery component 12 as seen in FIG.
5 and as described in greater detail below. After the first stage
67 of sealing material is installed, the expandable tamponading
member 21 is contracted and temporary sealing component 11 is
removed, leaving a bioabsorbable tip 23 behind as seen in FIG. 6. A
second stage 68 of sealing material is then installed in the
puncture PP as the sealing material delivery arrangement 12 is
removed as seen in FIG. 7.
[0051] Referring further to FIG. 1, the exemplary embodiment of the
sealing material delivery component 12 comprises a distal end 64, a
delivery tube 60, a first coupling 63, and a first sealing material
port 65. In alternate embodiments of the present invention there
may be multiple sealing material ports. The distal end 64 is the
opening through which the first and second stage sealing materials
67, 68 are deposited into the puncture PP. The delivery tube 60 may
be manufactured from any number of materials without departing from
the scope of the invention. In an embodiment, the delivery tube 60
is made of a polymeric material such as high-density polyethylene
(HDPE) or polyamide.
[0052] FIG. 1 also illustrates an exemplary cross section of
delivery tube 60 showing a double-barrel tube with cavities 31 and
32. The shape of cavities 31 and 32 can take a variety of forms.
Cavity 31 is the cavity through which the sealing material (first
stage 67 and/or second stage 68) passes on its way to exiting at
the distal end 64 and being deposited in the puncture PP. In
alternate embodiments of the invention, cavity 31 may be divided
into two or more cavities, where a different stage 67, 68 of
sealing material passes through each distinct cavity. Cavity 32 is
the space through which the temporary sealing component 11 passes
when the sealing system 10 is assembled. Cavity 32 also may be used
for delivery of sealing material, and particularly second stage
sealing material 68, when temporary sealing component 11 is removed
from cavity 32.
[0053] The sealing material used in the first and second stages 67,
68 of sealing the puncture PP may be any of a number of different
biocompatible materials as long as the material has the capability
of maintaining a seal in the puncture PP. For example, the sealing
material could be a liquid or gel that is flowable. The sealing
material can be a combination of liquid and solid materials, for
example, the first stage sealing material 67 could be a preformed
solid and the second stage sealing material 68 could be a flowable
material. In yet another embodiment, the sealing material can be a
compound that is mixed either prior to inserting the sealing
material into the sealing material delivery component 12 or that is
mixed as it passes through the sealing material delivery component
12. The sealing material may be a material that actually bonds the
body tissue BT at the puncture PP together such as a biocompatible
adhesive. In an embodiment described herein, the sealing material
is a polyethylene glycol based adhesive in a flowable state.
[0054] The exemplary temporary sealing component 11 illustrated in
FIG. 2 fits within cavity 32 of sealing material delivery component
12 so that the two components can be assembled into the sealing
system 10. The temporary sealing component 11 includes an elongate
flexible control member 20. Proximate to the distal end of the
control member 20 is mounted an expandable tamponading member 21.
In addition to serving a tamponading function, expandable member 21
also provides a locating function as described in connection with
FIG. 4 below. The control member 20 is configured so that the
distal end 22 and bioabsorbable tip 23 may pass through the guide
sheath GS into the blood vessel lumen BVL. The proximal end 24 of
member 20 connects with a second coupling 25 which includes an
expansion mechanism. The expansion mechanism controls the expansion
and contraction of the expandable tamponading member 21. The
expansion mechanism may take a variety of forms including a tube
for delivery of an expansion gas or liquid or springs, couplings or
other mechanical or electromechanical components for adjusting the
size of the expandable tamponading member 21. In an embodiment,
second coupling 25 includes a port or valve 28 for connection to a
syringe 26. The port 28 is connected to the proximal end 24 of
control member 20 and allows a gas or liquid from the syringe 26 to
expand and contract the expandable tamponading member 21. In its
collapsed condition, the expandable tamponading member 21 closely
adheres to the outside surface of control member 20. In its
expanded condition, the expandable tamponading member 21 is large
enough to seal the puncture PP in the body cavity as illustrated in
FIG. 4 and as described further below.
[0055] Second coupling 25 also includes a connector 14 to fix the
position of the temporary sealing component 11 to first coupling 63
of the sealing material delivery component 12. The connector 14 is
illustrated as a threaded member in the exemplary embodiment shown
in FIG. 2. However, connector 14 can take a variety of forms and
may be attached to first coupling 63 through a variety of attaching
mechanisms including springs, clips and various recesses or
protrusions.
[0056] The exemplary embodiment shown in FIG. 2 also illustrates a
cross section of control member 20 showing inflation lumen 30 and
wire 27. The inflation lumen 30 is the cavity through which the
liquid or gas passes to expand and contract the expandable
tamponading member 21. The wire 27 connects second coupling 25 to
the proximal end of bioabsorbable tip 23. As explained further
below, the bioabsorbable tip 23 may be detached from the wire 27
and deposited in the puncture PP to assist with sealing the
puncture PP. The bioabsorbable tip 23 can be made from a variety of
materials including polyethylene glycol, polylactic acid, collagen,
a bioadhesive glue, or a combination of these or other
bioabsorbable materials. It is understood that tip 23 alternatively
may be any biocompatible material that is not bioabsorbable, but
instead suitable for implantation in the body. Such a tip may be
either removed later or remain in the body.
[0057] It will be appreciated that the tamponading member 21 may be
mechanically, electrically, pneumatically or hydraulically expanded
and collapsed without departing from the scope of the invention.
The particular expanded exterior configuration of the tamponading
member 21 can be selected depending on the particular circumstances
of use. The criteria that is used to determine the particular size
and configuration is the blood vessel condition at the puncture PP
and the cross-sectional size and shape of the blood vessel lumen
BVL in the vicinity of the puncture PP. The largest cross-sectional
dimension of the expanded tamponading member 21 may be small enough
for the member 21 to be pulled back against the interior end of the
puncture PP without dragging or hanging up in the blood vessel
lumen BVL. It has been found that an expanded dimension in one
direction for the member 21 that is at least about 1.5 times larger
than the puncture PP is satisfactory to prevent the tamponading
member 21 from being pulled back through the puncture PP under
typical conditions.
[0058] One function of the tamponading member 21 is to seal the
body cavity so that fluid does not leak from the cavity in the
puncture PP. To achieve a seal, in an exemplary embodiment, the
portion of the tamponading member 21 near the puncture PP may be
larger in cross-sectional area than the cross-sectional area of the
puncture PP to insure sealing when the tamponading member 21 is
pulled back up against the interior end of the puncture PP. While
different expanded sizes may be used, dimensions on the order of
0.150-0.200 inch (3.8-5.1 mm) may be successful under typical
conditions where the puncture PP is made with a 4 french
needle.
[0059] Another function of the tamponading member 21 is to
positively locate the interior surface of the body cavity. Once the
temporary sealing component 11 is retracted so that the tamponading
member 21 is pulled back against the inside wall of the body
cavity, this may allow the surgeon to know the location of the body
cavity wall and to properly position the sealing material delivery
component 12.
[0060] Without limiting the scope of the invention, the particular
temporary sealing component 11 illustrated may be a balloon
catheter with the tamponading member 21 illustrated in FIG. 2 as a
small inflatable balloon which can be inflated. In the expanded
condition, the tamponading member 21 has a puncture facing surface
formed at the radius between the tamponading member 21 and control
member 20 that serves to substantially center the control member 20
in the end of the puncture PP and maintain the end of the puncture
PP closed. This is because the tamponading member 21 may shift in
the end of the puncture PP until the force exerted on the
tamponading member 21 by the blood vessel wall BVW and the body
tissue BT is equally distributed around the control member 20. The
tamponading member 21 is inflated and deflated through the control
member 20 as will become more apparent. The inflatable tamponading
member 21 may be made out of any suitable material such as latex.
In alternate embodiments where the tamponading member 21 is
mechanically expanded, it may be made of a metallic mesh which may
or may not include a flexible covering.
[0061] The control member 20 is a thin elongate flexible member
considerably smaller than the puncture PP. The diameter of the
control member 20 may be about 0.03 inch in procedures involving
the femoral artery. The control member 20 is sufficiently long to
extend from within the blood vessel lumen BVL out through the
puncture PP exteriorly of the patient so that it can be manually
manipulated. To permit the tamponading member 21 to be inflated,
the control member 20 defines an inflation lumen 30 therethrough
that extends from the valve 28, through second coupling 25, and to
the interior of the tamponading member 21 along the length of the
control member 20. Thus, the tamponading member 21 can be inflated
and deflated through the lumen 30 from a position external of the
patient.
[0062] The tamponading member 21 can be expanded and contracted by
any of a variety of mechanical, electromechanical, pneumatic, or
hydraulic techniques. As illustrated in the exemplary embodiment
shown in FIG. 2, the tamponading member 21 is inflated by any
convenient fluid inflation device such as syringe 26. The syringe
26 or other inflation device may be of the same type as that
already used in balloon angioplasty and is connected to the
exterior end of the control member 20 through valve 28 used to
selectively seal the inflation lumen 30. The inflation fluid under
pressure from the syringe 26 flows along the inflation lumen 30 in
the control member 20 into the tamponading member 21 to selectively
inflate same. The syringe 26 also is used to collapse the
tamponading member 21 when it is to be withdrawn as described
further below.
[0063] Referring to FIG. 3, an exemplary embodiment of the sealing
system 10 is illustrated as inserted through a guide sheath GS.
Typically the guide sheath GS may be in place in puncture PP in
connection with a surgical procedure. While the exemplary
embodiment shown in FIG. 3 involves inserting the sealing system 10
through a guide sheath GS, the guide sheath GS is not required for
use with the sealing system 10. When the surgical procedure is
completed, the sealing system 10 can be inserted through guide
sheath GS until delivery tube 60, control member 20, tamponading
member 21, and bioabsorbable tip 23 are positioned within the blood
vessel BV.
[0064] The exemplary embodiment shown in FIG. 3 illustrates the
first coupling 63 up against the hub 70 of the guide sheath GS. In
certain embodiments, the first coupling 63 of sealing system 10 may
be attached to the hub 70 of guide sheath GS. Such an attaching
feature can be useful for fixing the position of the sealing system
10 relative to the guide sheath GS. The first coupling 63 may be
attached to the hub 70 of guide sheath GS through a variety of
mechanisms including threads, clips, snaps, protrusions, or
recesses.
[0065] Once the tamponading member 21 is within the blood vessel
BV, it can be inflated so that its cross-sectional area is larger
than the cross-sectional area of the puncture PP. While not shown
in FIG. 3, the tamponading member 21 is inflated using an expanding
mechanism such as syringe 26 shown in FIG. 2. In this exemplary
embodiment, the syringe 26 is coupled to valve 28 and a fluid or
gas is pushed from the syringe 26, through the inflation lumen 30
in control member 20, and into the tamponading member 21.
[0066] Referring to FIG. 4, an exemplary embodiment of sealing
system 10 is illustrated with the sealing system 10 in a retracted
position. In the embodiment shown in FIG. 4, both the sealing
system 10 and the guide sheath GS have been retracted so that
tamponading member 21 has been pulled up against the puncture PP in
the blood vessel wall BVW. Because the tamponading member 21 has
been inflated to a cross-sectional size greater that the
cross-sectional size of the puncture PP, the tamponading member 21
remains up against the blood vessel wall BVW and may not pass into
the puncture PP.
[0067] Retracting the exemplary sealing system 10 as shown in FIG.
4 allows the surgeon to create a seal with the tamponading member
21 pulled up against the interior of the blood vessel wall BVW.
Creating a seal in the puncture PP prevents blood from flowing up
into the puncture and creates a relatively dry environment in the
puncture PP in preparation for depositing sealing material into the
puncture PP. The surgeon may also confirm that the puncture PP in
the blood vessel wall BVW is sealed by using a syringe to draw a
vacuum through cavity 31 in delivery tube 60. If the syringe draws
blood from the puncture PP through the cavity 31, this may indicate
to the surgeon that the puncture PP is not properly sealed at the
blood vessel wall BVW.
[0068] Retracting the sealing system 10 so that the tamponading
member 21 is pulled up against the interior of the blood vessel
wall BVW also allows the surgeon to confirm the location of the
sealing system 10 and the delivery tube 60 within the puncture PP.
In certain embodiments, the surgeon may install a clip onto the
shaft of delivery tube 60 to mark where the delivery tube 60 exits
the skin SK. This mark on the delivery tube 60 may serve to
positively locate the distal end 64 of delivery tube 60 with
respect to the blood vessel wall BVW, even after the tamponading
member 21 is contracted and withdrawn as described below.
[0069] In the retracted position illustrated in FIG. 4, the
delivery tube 60 of the sealing material delivery component 12 has
been retracted to a position where its distal end 64 is located
within the puncture PP but proximate to the distal end of the
puncture PP. The relative location of the distal end 64 of the
delivery tube 60 with respect to the tamponading member 21 can be
adjusted depending on the type of procedure and the patient.
[0070] Referring to FIG. 5, an exemplary embodiment of the sealing
system 10 is illustrated performing the deposit of the first stage
of sealing material 67 in the puncture PP. The first stage of
sealing material 67 can be mixed outside of the sealing system 10,
for example, in a double-barrel syringe (not shown). The mixed
first stage of sealing material 67 is then injected into first
sealing material port 65 and flows through cavity 31 in delivery
tube 60. In alternate embodiments of the invention, the first stage
sealing material 67 can be mixed in cavity 31 as it flows along the
inside of the delivery tube 60. As illustrated in FIG. 5, the
distal end 64 of delivery tube 60 has been positioned proximate to
the blood vessel wall BVW. The first stage sealing material 67
exits the delivery tube 60 at the distal end 64 and is deposited in
the region immediately proximate to the blood vessel wall BVW
creating a seal where the puncture PP passed through the blood
vessel wall BVW. However, as illustrated in FIG. 5, the seal
created with the first stage sealing material 67 may not be a
complete seal because control member 20 still passes through the
first stage sealing material 67 and into the blood vessel BV.
[0071] In alternate embodiments, the first stage sealing material
67 can be a solid material with a preformed hollow center through
which the control member 20 passes. The solid material with the
preformed hollow center can be pushed into the puncture PP or
deposited in the puncture PP by a modified version of the sealing
system 10 so that the solid material is positioned proximate to the
blood vessel wall BVW.
[0072] Referring to FIG. 6, the exemplary sealing system 10 is
illustrated with the step of removing the temporary sealing
component 11. In this step of the exemplary procedure, first the
tamponading member 21 is contracted by releasing the valve 28 so
that the liquid or gas can pass out of the tamponading member 21,
back up the inflation lumen 30 and into the syringe 26 (not shown).
Once the tamponading member 21 is contracted, the surgeon can
rotate the second coupling 25 as shown in the exemplary embodiment
in FIG. 6. Rotating the second coupling 25 causes the temporary
sealing component 11 to retract and separate from the sealing
material delivery component 12.
[0073] As shown in FIG. 6, in an embodiment of the sealing system
10, the second coupling 25 is attached to the first coupling 63
using threads. The threads allow the second coupling 25 and the
temporary sealing component 11 to be gently separated from the
sealing material delivery component 12. In alternate embodiments of
the sealing system 10, the second coupling 25 and the first
coupling 63 can be connected and detached using alternate
mechanisms such as clips, snaps, protrusions, or recesses.
[0074] Retracting the temporary sealing component 11 removes the
contracted tamponading member 21 and the control member 20 from the
blood vessel BV and through the first stage sealing material 67.
However, retraction of the tamponading member 21 and the control
member 20 through the first stage sealing material 67 leaves an
opening in the first stage sealing material 67 called a tract (not
shown). Furthermore, depending on the type of first stage sealing
material 67 used, it may be difficult to retract the control member
20 from the first stage sealing material 67. Certain embodiments of
the sealing system 10 may employ an additional sheath (not shown)
around the control member 20 where the additional sheath is made of
a material that resists adhesion to the first stage sealing
material 67 and facilitates retraction of the control member 20
from the first stage sealing material 67.
[0075] Referring to the hollow passage or tract in the first stage
sealing material 67, as the temporary sealing component 11 is
further retracted, the bioabsorbable tip 23 may pass into the tract
in the first stage sealing material 67 and serve to fill the hollow
space defined by the tract. In this way the bioabsorbable tip 23
provides an improved method for completely sealing the puncture PP.
A variety of mechanisms may be employed to release the
bioabsorbable tip 23 from the wire 27 so that it may be deposited
in the tract in the first stage sealing material 67. For example,
in an embodiment, the bioabsorbable tip 23 is larger in diameter
than the distal end 64 of the delivery tube 60. As the temporary
sealing component 11 is retracted, the bioabsorbable tip 23 engages
the distal end 64 of delivery tube 60 and with sufficient tension,
the bioabsorbable tip 23 breaks off of the wire 27 and remains in
the tract. In alternate embodiments of the invention, the
bioabsorbable tip 23 may be released from the temporary sealing
component 11 using a mechanical or electro-mechanical release
mechanism. In yet other embodiments of the invention, the
bioabsorbable tip 23 can be designed to fracture under a certain
tension so that a portion of the bioabsorbable tip 23 breaks free
of the wire 27 and is deposited in the tract.
[0076] Referring to FIG. 7, an exemplary embodiment of the sealing
system 10 is illustrated with the temporary sealing component 11
having been removed as described in connection with FIG. 6. FIG. 7
illustrates the final step of the exemplary sealing process,
namely, the depositing of the second stage sealing material 68 in
the puncture PP. As illustrated in FIG. 7, the bioabsorbable tip 23
remains within the tract in the first stage sealing material 67
proximal to the blood vessel wall BVW. The second stage sealing
material 68 can be used to fill the remainder of the puncture PP as
well as to seal off any remaining gaps in and around the tract and
the first stage sealing material 67. The second stage sealing
material 68 may either have the same or a different composition
from the first stage sealing material 67.
[0077] In an embodiment, the second stage sealing material 68 is
mixed outside the sealing system 10, for example, in a
double-barrel syringe, and is injected into the first sealing
material port 65. However, in this embodiment the second stage
sealing material 68 flows through cavity 32 because cavity 31 may
be impassable because it is filled with the first stage sealing
material 67 which may have set. In an embodiment, cavity 32 may
have a one-way valve so that the second stage sealing material 68
passes down the cavity 32 toward the distal end 64 and not in the
opposite direction and out the proximal end of first coupling 63.
In one alternate embodiment of the sealing system 10, the second
stage sealing material 68 is injected through a second sealing
material port (not shown). In another alternate embodiment of the
sealing system 10, the second stage sealing material 68 is not
mixed until it passes along the cavity 32 within the delivery tube
60. In yet another alternate embodiment of the sealing system 10,
there may be additional cavities along the length of delivery tube
60 permitting components of the second stage sealing material 68 to
remain separate until they are deposited and mixed in the puncture
PP.
[0078] As shown in FIG. 7, the second stage sealing material 68
exits the distal end 64 of delivery tube 60 and fills the remainder
of the puncture PP. As the second stage sealing material 68 is
deposited, the surgeon can retract the sealing material delivery
component 12. The second stage sealing material 68 can be used to
completely fill and seal the puncture PP.
[0079] FIG. 8 shows an embodiment of a sealing system 112 including
temporary sealing component 11. In the embodiment of the sealing
system 112 shown in FIG. 8, the guide sheath GS remains through the
skin SK and body tissue BT during the closure of the percutaneous
puncture PP.
[0080] The exemplary embodiment shown in FIG. 8 illustrates a
coupling 71 disposed up against hub 70 of the guide sheath GS. In
certain embodiments, the coupling 71 of sealing system 112 may be
attached to hub 70 of the guide sheath GS. Such an attaching
feature can be useful for fixing the position of the sealing system
112 relative to the guide sheath GS.
[0081] An additional benefit of having guide sheath GS remain
through the skin SK and body tissue BT is that the guide sheath GS
seals the tract and/or acts as a cork and provides a confined space
that forces the sealing material to remain within the body tissue
BT.
[0082] Another benefit of having guide sheath GS remain through the
skin SK and body tissue BT is the ability to aspirate any fluid
that may be present within the body tissue BT tract. A syringe can
be attached to luer fitting 76 to apply a vacuum and aspirate fluid
from body tissue BT.
[0083] A benefit of aspirating any fluid or blood from tract
puncture PP is the ability to verify that the tamponading member 21
has been pulled up against blood vessel wall BVW and has sealed the
puncture PP.
[0084] Coupling 71 may be attached to hub 70 with a variety of
means and at a variety of locations. For example, coupling 71 may
be attached to the outside or inside of hub 70, to proximal or
distal ends of hub 70, or onto the shaft 74, 75 of guide sheath GS.
The coupling 71 may be attached to the hub 70 of the guide sheath
GS through a variety of mechanisms including threads, clips, snaps,
protrusions or recesses.
[0085] FIGS. 9 and 10 show an exemplary embodiment of the sealing
system 112 inserted through guide sheath GS. In the exemplary
embodiment shown in FIGS. 9 and 10, the guide sheath GS remains in
the tract and guide sheaths GS of different lengths may be
accommodated.
[0086] Guide sheath GS may be in place in puncture PP in connection
with a surgical procedure. Guide sheath GS may be manufactured in a
variety of different shapes and lengths and the following will
illustrate how to accommodate for the variability of guide sheath
lengths.
[0087] Referring to FIG. 9, sealing system 112 is inserted through
the guide sheath GS until tamponading member 21 exits the distal
end of guide sheath GS. The tamponading member 21 is activated to
an expanded state and sealing system 112 is withdrawn until the
distal end of guide sheath GS is in contact with tamponading member
21. Coupling 71 is advanced distally until coupling component 86 is
in contact and secured to hub 70 of guide sheath GS. Coupling 71
allows sealing system 112 to be attached to hub 70, and the distal
end of guide sheath GS to be within a known distance from
tamponading member 21, as will be described. Coupling component 84
is secured to delivery tube 60. Coupling component 84 can be
attached to delivery tube 60 through a variety of mechanisms
including threads, clips, snaps, protrusions or recesses.
[0088] Coupling 71 may include coupling components 84, 85, 86, as
shown in FIG. 9. Coupling component 86 may be slidably received in
coupling component 85, and coupling component 85 may be slidably
received in coupling component 84 to allow for telescoping movement
between coupling components 84, 85, 86. The telescoping movement
allows the length of coupling 71 (i.e., the distance between the
distal end of coupling component 86 or hub 70, and the proximal end
of coupling component 84) to be adjustable between length X shown
in FIG. 9 to length Y shown in FIG. 10. Accordingly, the length of
coupling 71 is adjustable between length X when coupling 71 is in
an extended configuration and length Y when coupling 71 is in a
collapsed configuration.
[0089] Attachment of coupling 71 to guide sheath GS provides a
means of setting a defined distance between tamponading member 21,
distal end of guide sheath GS and distal end of delivery tube 60.
Referring to FIG. 10, once coupling 71 is attached to hub 70, a
coupling release mechanism 87 is activated to allow components 85
and 86 to compress (or telescope) together into coupling component
84. Release mechanism 87 can be made by a variety of mechanisms
including threads, clips, snaps, protrusions or recesses. For
example, release mechanism 87 may include a push button attached to
a spring release that permits coupling components 84, 85, 86 to
telescope into the collapsed configuration shown in FIG. 10 after
pressing the push button.
[0090] Since coupling component 84 is secured to delivery tube 60
and coupling component 86 is secured to hub 70 of guide sheath GS,
when coupling 71 is collapsed, delivery tube 60 and hub 70 of guide
sheath GS are moved with respect to each other. Since tamponading
member 21 is connected to delivery tube 60 via connector 14, guide
sheath GS also moves with respect to tamponading member 21. The
distance that the guide sheath GS moves with respect to tamponading
member 21 may generally equal the distance that coupling 71 is
shortened (length X-length Y).
[0091] Shortening or collapsing coupling 71 retracts guide sheath
GS from tamponading member 21 to a set distance (length X-length
Y). The set distance between tamponading member 21 and the distal
end of guide sheath GS may be 10 mm (0.3937 inch). The set distance
can range from 2 mm-20 mm (0.079-0.79 inch). Physicians use a
variety of different length guide sheath GS and the method
described above provides a means of adjusting and/or consistently
setting a distance between the distal end of the guide sheath GS
and the tamponading member 21 independent of guide sheath GS
length. As a result, coupling 71 allows the physician to move guide
sheath GS with respect to tamponading member 21 without pulling
guide sheath GS out of puncture PP. Shortening coupling 71 also
creates sufficient space between the distal end of guide sheath GS
and tamponading member 21 for injecting sealing material.
[0092] FIG. 11 shows a further embodiment of the sealing system 112
including temporary sealing component 11. In this embodiment, a
known tension may be applied to the sealing system 112. As shown in
FIG. 11, the sealing system 112 has been retracted so that
tamponading member 21 has been pulled up against the puncture PP in
the blood vessel wall BVW. To reduce the variability of the amount
of tension that is applied to sealing system 112 and the blood
vessel wall BVW, a hub 72 and compression spring 73 may be
provided.
[0093] Delivery tube 60 may be slidably received in hub 72, and hub
72 may be connected to a distal end of compression spring 73. A
proximal end of compression spring 73 may be connected to a distal
end of first coupling 63. The physician may hold on to and pull hub
72 in the proximal direction (as shown by the arrows in FIG. 11),
thereby compressing compression spring 73 and forcing sealing
system 112 (e.g., first or second couplings 63, 25) in the proximal
direction. As a result, tamponading member 21, which is attached to
second coupling 25 by control member 20, is pulled upward against
blood vessel wall BVW. The physician may pull hub 72 and sealing
system 112 and compress compression spring 73 until a desired force
is applied to blood vessel wall BVW.
[0094] A scale 61 with numerical indices could be used to help
guide the physician to apply a consistent amount of tension. The
numerical indices may correspond to the amount of compression of
compression spring 73 and may be provided, e.g., on an outer
surface of delivery tube 60, as shown in FIG. 11. Applying a known
load to sealing system 112 may permit the positioning of
tamponading member 21 at a set distance from puncture PP
consistently during the delivery of first stage delivery material
67 and bioabsorbable tip 23. Alternatively, or in addition to using
compression spring 73, hub 72 may be attached to a variety of other
mechanisms including a compression spring, an expansion spring, a
polymer band, or other stretchable and/or biasing member.
[0095] FIG. 11 shows an embodiment of sealing system 112 in which a
skin securement hub 77 may be attached to guide sheath GS. Once a
load is applied to sealing system 112 as described above, skin
securement hub 77 may be attached to skin SK. Guide sheath GS may
be inserted into and positioned within skin securement hub 77, as
shown in FIG. 11. Skin securement hub 77 includes a cover 78, which
may be closed to secure skin securement hub 77 to guide sheath GS
and to secure guide sheath GS and sealing system 112 in position.
For example, closing cover 78 onto skin securement hub 77 may cause
skin securement hub 77 to be squeezed, compressed, or locked onto
guide sheath GS. Skin securement hub 77 can be secured to skin SK
using adhesive tape or secured mechanically under skin SK.
[0096] Securing the position of sealing system 112 maintains a
consistent distance between delivery tube 60 and tamponading member
21 during delivery of the first stage sealing material 67. An
additional benefit of securing sealing system 112 in position is
that the delivery tube 60 position is maintained during the removal
of tamponading member 21 and the separation of bioabsorbable tip
23. Securing sealing system 112 in place also maintains a
consistent deployment location of the bioabsorbable tip 23. Also,
maintaining position of sealing system 112 with skin securement hub
77 may maintain a consistent delivery location for delivering
second stage sealing material 68. Securing sealing system 112 in
place with skin securement hub 77 also allows the physician to free
one or more hands, which would have been used to hold sealing
system 112 in place.
[0097] FIG. 12 shows an additional embodiment of sealing system 112
secured to a skin securement hub 79 that is attached to delivery
tube 60. Skin securement hub 79 may include a cover, e.g., cover
78, and may be secured to delivery tube 60 in a similar manner as
described above for securing skin securement hub 77 to guide sheath
GS.
[0098] Skin securement tube 79 includes a tube 80 inserted through
skin SK and body tissue BT. Instead of guide sheath GS, tube 80 may
seal the tract, act as a cork, and provide a confined space that
forces the first stage sealing material 67 to remain within body
tissue BT. A syringe can be attached to luer fitting 81 to apply a
vacuum and aspirate fluid from body tissue BT prior to delivery of
first stage sealing material 67. Skin securement hub 79 can be
secured to skin SK using frictional engagenement or adhesive tape,
or is secured mechanically under skin SK.
[0099] FIG. 13 shows an additional embodiment of sealing system 112
in which delivery tube 60 is retracted prior to delivery of second
stage sealing material 68 by retracting coupling 71 from hub 70. A
syringe may be attached to a luer fitting 82 in first coupling 63,
and luer fitting 82 may be fluidly connected to cavity 31 (FIG. 1)
in delivery tube 60 so that first stage sealing material 67 may be
delivered from the syringe through cavity 31 in delivery tube 60.
After passing through cavity 31, first stage sealing material 67
may seal or block cavity 31. A luer fitting 83 may be provided in
first coupling 63 and fluidly connected to cavity 32 (FIG. 1) in
delivery tube 60. A syringe may be attached to luer fitting 83 to
deliver second stage sealing material 68 through cavity 32 in
delivery tube 60.
[0100] Prior to delivery of second stage sealing material 68,
coupling 71 may be separated from hub 70 to retract coupling 71
from hub 70. While different separation distances may be used,
distances on the order of 1-10 mm (0.039-0.39 inch) may be
desirable. Alternatively, the retraction of coupling 71 from hub 70
could take place without separating the two components. Coupling 71
and hub 70 could be connected by a hinge mechanism, slide or
telescoping tubes (not shown) that allows the physician to retract
coupling 71 from hub 70, and retract delivery tube 60 to a
predetermined distance. Delivery tube 60 may be retracted so that
the distal end of delivery tube 60 is approximately flush with the
distal end of guide sheath GS, or so that the delivery tube 60
extends outward from or inward into the distal end of the guide
sheath GS up to a distance, e.g., 5 mm, which may be a
predetermined distance. Once delivery tube 60 is retracted, second
stage sealing material 68 can be delivered through luer fitting 83.
The delivery of second stage sealing material 68 seals the
remaining channel.
[0101] The above disclosure discusses the delivery of second stage
sealing material 68, but closure could be completed with only the
delivery of first stage sealing material 67 and the delivery of
bioabsorbable tip 23.
[0102] FIG. 14 shows an additional embodiment that allows the
second stage sealing material 68 to be delivered through the guide
sheath GS. Prior to delivery of the second stage sealing material
68 the tamponading member 21 and sealing system 112 are removed
from the guide sheath GS. Bioabsorbable tip 23 remains in the
tract. The second stage sealing material 68 is supplied through
luer 76 of the guide sheath GS. The second stage sealing material
68 is injected through the guide sheath GS and seals the remaining
channel.
[0103] FIG. 15 shows an additional embodiment of sealing system 112
having an expandable member 88 fixedly attached to delivery tube 60
and expanded within body tissue BT. Sealing system 112 is inserted
through guide sheath GS. Tamponading member 21 is expanded and
sealing system 112 is retracted so that tamponading member 21 is
pulled up against the puncture PP in the blood vessel wall BVW.
Guide sheath GS is retracted from body tissue BT.
[0104] Delivery tube 60 may include an additional channel (not
shown) fluidly connecting expandable member 88 to a luer 89 in
first coupling 63. A syringe may be attached to luer 89 to deliver
gas or liquid through the channel in delivery tube 60 to expand or
contract the expandable member 88.
[0105] Expandable member 88 provides numerous benefits. For
example, the position of sealing system 112 may be secured to
maintain a consistent distance between delivery tube 60 and
tamponading member 21 during delivery of the first stage sealing
material 67. An additional benefit of securing sealing system 112
in position is that the delivery tube 60 position is maintained
during the removal of tamponading member 21 and the separation of
bioabsorbable tip 23. Securing sealing system 112 in place
maintains a consistent deployment location of the bioabsorbable tip
23. Also, maintaining position of sealing system 112 may maintain a
consistent delivery location for delivering second stage sealing
material 68. An additional benefit of expanding expandable member
88 is that the expandable member 88 seals the tract and/or acts as
a cork and provides a confined space that forces the sealing
material to remain within the body tissue BT. The expandable member
88 can be created by many means, such as, expandable balloon,
expandable disc, telescoping tubes, etc.
[0106] FIG. 16 shows an additional embodiment of sealing system 112
with expandable member 88 fixedly attached to delivery tube 60 and
expanded within guide sheath GS. Sealing system 112 is inserted
through guide sheath GS. Tamponading member 21 is expanded and
sealing system 112 is retracted so that tamponading member 21 is
pulled up against the puncture PP in the blood vessel wall BVW.
Guide sheath GS is retracted and secured onto coupling 71. A
syringe may be attached to luer 89 as described above to deliver
gas or liquid through the channel in delivery tube 60 to expand or
contract the expandable member 88.
[0107] Expandable member 88 provides numerous benefits. For
example, the expandable member 88 seals the guide sheath GS and/or
acts as a cork and prevents the first stage delivery material 67
from entering the guide sheath GS. An additional benefit is the
ability to center the sealing system 112 and control member 20
within the percutaneous puncture PP. Centering control member 20
may help facilitate centering the hollow space or tract within
first stage sealing material 67 and positioning bioabsorbable tip
23 within the center of the percutaneous puncture PP. This is
beneficial when closing larger bore percutaneous punctures PP, such
as punctures PP produced by a 12-24 french guide sheath. The
position of the expandable member could be completely within the
guide sheath GS or partially exiting the distal end of guide sheath
GS.
[0108] According to another exemplary embodiment, the tamponading
member 21 may serve as a bioabsorbable tip, and a separate
bioabsorbable tip (e.g., bioabsorbable tip 23) may be omitted.
Referring to the hollow passage or tract in the first stage sealing
material 67, as the tamponading member 21 is collapsed and
retracted, the tamponading member 21 passes into the tract in the
first stage sealing material 67 and serves to fill the hollow space
defined by the tract. In this way, the tamponading member 21 may
become the bioabsorbable tip 23 and may provide an improved method
for completely sealing the puncture PP. Tamponading member 21
and/or bioabsorbable tip 23 can be made from a variety of materials
including polyethylene glycol, polylactic acid, polyglycolic acid,
collagen, poly-ether-ester or a combination of these or other
bioabsorbable materials. Alternatively, tamponading member 21
and/or tip 23 may be nonbioabsorbable. Other materials for forming
tamponading member 21 and/or tip 23 may include stainless steel,
titanium, nitinol, P.E.E.K., P.E.T., silk, hydrogel, a two-part
liquid compound, etc. A variety of mechanisms may be employed to
release tamponading member 21 from the catheter so that it may be
deposited in the tract in the first stage sealing material 67. For
example, tamponading member 21 may be released using a mechanical
or electro-mechanical release mechanism, including any of the
mechanisms described in this diclosure, or by fracturing or
breaking off a portion of tamponading member 21.
[0109] FIGS. 17-19 show an exemplary embodiment of sealing system
112 with an insert member 92 attached to control member 20. Insert
member 92 creates a hollow cavity 90, which may be a hollow
geometry pocket with a defined shape within first stage sealing
material 67. The size and/or shape of hollow cavity 90 may be
similar to the size and/or shape of bioabsorbable tip 23. During
the withdrawal of temporary sealing component 11 from first stage
sealing material 67, bioabsorbable tip 23 may be disconnected from
temporary sealing component 11 and positioned within hollow cavity
90.
[0110] As shown in FIG. 17, insert member 92 on control member 20
may be positioned in percutaneous puncture PP during the delivery
of first stage sealing material 67.
[0111] As shown in FIG. 18, after first stage sealing material 67
is delivered and set, one or more hollow cavities 90, 91 may be
formed in first stage sealing material 67. For example, hollow
cavity 90 may be created by removing insert member 92 from first
stage sealing material 67 after first stage sealing material 67 has
set, and/or hollow cavity 91 may be created by removing delivery
tube 60 from first stage sealing material 67 after first stage
sealing material 67 has set.
[0112] As shown in FIG. 19, when insert member 92 on control member
20 of temporary sealing component 11 is retracted, bioabsorbable
tip 23 may be positioned within hollow cavity 90 and released as
described above in connection with FIGS. 6 and 7, or in any other
suitable fashion. Second stage sealing material 68 may be delivered
within hollow cavity 91.
[0113] Hollow cavity 90 may have one of many different shapes
depending on the geometry of insert member 92. Insert member 92 may
be smaller or approximately the same size as bioabsorbable tip 23.
Hollow cavity 90 may be smaller than bioabsorbable tip 23 to help
secure bioabsorbable tip 23 and prevent second stage sealing
material 68 from traveling distally during injection of second
stage sealing material 68.
[0114] Insert member 92 may have a fixed shape or may be expandable
to create a larger shape prior to the delivery of first stage
delivery material 67. For example, expandable insert member 92 may
be a balloon. Expandable insert member 92 may be positioned in
percutaneous puncture PP in a nonexpanded condition and expanded
prior to delivering first stage sealing material 67 to the
percutaneous puncture PP (FIG. 17). After delivering first stage
sealing material 67, the expanded insert member 92 may be changed
to its nonexpanded shape and removed from hollow cavity 90 (FIG.
18). Then, bioabsorbable tip 23 may be positioned within hollow
cavity 90 (FIG. 19).
[0115] Alternatively, insert member 92 may be formed from a
flexible (e.g., a gummy, elastic, etc.) material that allows insert
member 92 to change shape and/or be squeezed to allow insert member
92 to be inserted into and removed from hollow cavity 90. The
expandable insert member 92 may be positioned in percutaneous
puncture PP in an unstressed (or normal) shape and/or condition
prior to delivering first stage sealing material 67 to the
percutaneous puncture PP (FIG. 17). After delivering first stage
sealing material 67, control member 20 may be pulled proximally
with respect to the puncture so that insert member 92 is pulled out
of hollow cavity 90 (FIG. 18). As insert member 92 is pulled,
insert member 92 may change shape and/or be squeezed through a
narrower cavity formed by control member 20 in first stage sealing
material 67 proximal to hollow cavity 90 (e.g., a narrow cavity
formed between hollow cavity 90 and hollow cavity 91). Then,
bioabsorbable tip 23 may be positioned within hollow cavity 90
(FIG. 19).
[0116] The shape of insert member 92 may be one of the various
shapes described in this disclosure for bioabsorbable tip 23.
Insert member 92 may be formed of one or more of the materials
described above for forming bioabsorbable tip 23. Insert member 92
may be formed integrally with control member 20, or may be formed
separate from control member 20 and attached to control member
20.
[0117] A variety of methods may be used to determine and monitor
the location of bioabsorbable tip 23 prior to its separation from
temporary sealing component 11. As described above, pulling
tamponading member 21 against the interior of blood vessel wall BVW
allows the surgeon to confirm the location of sealing system 10,
112 and delivery tube 60. Also, a clip may be installed on delivery
tube 60 to indicate where delivery tube 60 exits skin SK and to
assist in determining the distance between distal end 64 of
delivery tube 60 and blood vessel wall BVW. Then, the location of
bioabsorbable tip 23 may be determined based on the location of
distal end 64 of delivery tube 60 since the distance between
temporary sealing component 11 and sealing material delivery
component 12 (e.g., adjusted using connector 14) is known.
[0118] Blood pressure may also be used to assist the user to
identify the position of bioabsorbable tip 23 prior to its
detachment from temporary sealing component 11. A pressure
transducer (not shown) may be attached to temporary sealing
component 11 and may provide an arterial pressure reading that may
be recorded while temporary sealing component 11 is within blood
vessel lumen BVL. While temporary sealing component 11 is withdrawn
from blood vessel lumen BVL, the arterial pressure may be monitored
until a pressure drop occurs (e.g., when pressure drops a
predetermined amount), which may indicate that bioabsorbable tip 23
is positioned within first stage sealing material 67.
[0119] Another method of identifying the location of bioabsorbable
tip 23 is with the use of blood flow. Temporary sealing component
11 may include a lumen (not shown), e.g., located in wire 27 with a
distal opening that is distal or proximal to bioabsorbable tip 23.
The user may allow a small amount of blood to flow through the
lumen while bioabsorbable tip 23 is within blood vessel lumen BVL.
Stoppage of the blood flow in the lumen may indicate that
bioabsorbable tip 23 is withdrawn and positioned within first stage
sealing material 67.
[0120] Another method of identifying the location of bioabsorbable
tip 23 is with the use of fluoroscopy or other imaging techniques
used to view internal structures of a patient. A radiopaque filler
or marker or other type of identifiable material may be placed
within bioabsorbable tip 23. The user may watch, e.g., on a
fluoroscope, the movement of the radiopaque marker to identify when
bioabsorbable tip 23 is positioned within first stage sealing
material 67. Radiopaque fillers or markers may also be added to
first stage sealing material 67 to help visualize first stage
sealing material 67 during delivery.
[0121] Bioabsorbable tip 23 may be formed in one of a variety of
shapes. For example, as shown in FIGS. 2-17, bioabsorbable tip 23
may be elongate with a cylindrical, rectangular, or other type of
cross section. FIGS. 20-27 show exemplary embodiments of the
various shapes that bioabsorbable tip 23 may have.
[0122] FIG. 20 shows an embodiment of bioabsorbable tip 23 with a
body 94, and one or more barbs 93 secured to the sides of body 94.
Barbs 93 may be flexible and may allow bioabsorbable tip 23 to pass
through first stage sealing material 67 in one direction, e.g.,
proximally, with a small amount of resistance. Barbs 93 may open or
catch, and become engaged or lock on to first stage sealing
material 67 to prevent bioabsorbable tip 23 from moving distally.
Barbs 93 may be made of rigid, semi-rigid, or soft materials. As
shown in FIG. 20, barbs 93 may be pointed or tapered, and may
extend from body 94 at an angle relative to a longitudinal axis of
body 94. Barbs 93 may be angled towards a distal end of body 94.
Barbs 93 may provide a liquid seal between bioabsorbable tip 23 and
first stage sealing material 67. As a result, when delivering
second stage sealing material 68, barbs 93 may prevent second stage
sealing material 68 from entering blood vessel lumen BVL. Barbs 93
may also prevent blood from flowing proximally past bioabsorbable
tip 23.
[0123] FIG. 21 shows an embodiment of bioabsorbable tip 23 with a
body 96, and one or more rings 95 around body 96. Rings 95 may be
constructed of the same material as body 96 and may be formed
integral with body 96. Rings 95 may be flexible or rigid. Rings 95
may provide stability to bioabsorbable tip 23 within first stage
sealing material 67. Rings 95 may also provide a liquid seal
between bioabsorbable tip 23 and first stage sealing material 67.
As a result, when delivering second stage sealing material 68,
rings 95 may prevent second stage sealing material 68 from entering
blood vessel lumen BVL. Rings 95 may also prevent blood from
flowing proximally past bioabsorbable tip 23.
[0124] FIG. 22 shows an embodiment of bioabsorbable tip 23 with a
body 98, and one or more rings 97 around body 98. Rings 97 may be
made of a different material than body 98. Rings 97 may be flexible
or rigid. Rings 97 may provide stability to bioabsorbable tip 23
within first stage sealing material 67. Rings 97 may also provide a
liquid seal between bioabsorbable tip 23 and first stage sealing
material 67. As a result, when delivering second stage sealing
material 68, rings 97 may prevent second stage sealing material 68
from entering blood vessel lumen BVL. Rings 97 may also prevent
blood from flowing proximally past bioabsorbable tip 23.
[0125] FIG. 23 shows an embodiment of bioabsorbable tip 23 that is
expandable. For example, bioabsorbable tip 23 may be formed from
expandable materials, such as materials that expand when in contact
with a liquid, e.g., blood. Alternatively, bioabsorbable tip 23 may
include an expandable structure, e.g., an expandable balloon, and
the size of the expandable structure may be controlled by the user.
Bioabsorbable tip 23 may enter blood vessel lumen BVL in the
smaller, unexpanded configuration 99, and may be opened or expanded
to the larger, expanded configuration 100 when in contact with
blood or otherwise activated. The expanded configuration 100 may
provide stability to bioabsorbable tip 23 within first stage
sealing material 67. When expanded, a liquid seal may form between
bioabsorbable tip 23 and first stage sealing material 67. As a
result, when delivering second stage sealing material 68, expanded
configuration 100 of bioabsorbable tip 23 may prevent second stage
sealing material 68 from entering blood vessel lumen BVL. Expanded
configuration 100 of bioabsorbable tip 23 may also prevent blood
from flowing proximally past bioabsorbable tip 23.
[0126] FIG. 24 shows an embodiment of bioabsorbable tip 23
including a suture 120. Suture 120 may include a main body 121 with
a knot 122 tied within main body 122 of suture 120.
[0127] FIG. 25 shows an embodiment of bioabsorbable tip 23
including a suture 130. Suture 130 may include a main body 131 with
a knot 132 tied within main body 131 of suture 130. A flexible or
rigid disc 133 may be located on suture 130 proximal to the knot
132.
[0128] Each suture 120, 130 shown in FIGS. 24 and 25 may provide
stability to bioabsorbable tip 23 within first stage sealing
material 67. Each suture 120, 130 may also provide a liquid seal
between bioabsorbable tip 23 and first stage sealing material 67.
As a result, when delivering second stage sealing material 68, each
suture 120, 130 may prevent second stage sealing material 68 from
entering blood vessel lumen BVL. Each suture 120, 130 may also
prevent blood from flowing proximally past bioabsorbable tip
23.
[0129] FIG. 26 shows an embodiment of bioabsorbable tip 23
including a braid configuration. The braid may be stretched to a
lower picks per inch configuration 101 and compressed to a higher
picks per inch 102 configuration. The higher picks per inch
configuration 102 increases an outer dimension of the braid (e.g.,
the thickness, width, diameter, etc., of the braid) to assist in
securing bioabsorbable tip 23 within first stage sealing material
67. The lower picks per inch configuration 101 provides a smaller
outer dimension that may facilitate delivery of bioabsorbable tip
23 within first stage sealing material 67. The braid may include a
plurality of strands that are braided together so that, when second
stage delivery material 68 is delivered, second stage sealing
material 68 may mold around the individual strands of the braid to
help secure bioabsorbable tip 23 in place. In higher picks per inch
configuration 102, the braid may provide stability to bioabsorbable
tip 23 within first stage sealing material 67, and a liquid seal
may form between bioabsorbable tip 23 and first stage sealing
material 67. As a result, when delivering second stage sealing
material 68, higher picks per inch configuration 102 of
bioabsorbable tip 23 may prevent second stage sealing material 68
from entering blood vessel lumen BVL. Higher picks per inch
configuration 102 of bioabsorbable tip 23 may also prevent blood
from flowing proximally past bioabsorbable tip 23. Alternatively,
bioabsorbable tip 23 may include other configurations that are
capable of stretching to decrease an outer dimension of
bioabsorbable tip 23 and compressing to increase an outer dimension
of bioabsorbable tip 23, such as a bellows-like configuration.
[0130] FIG. 27 shows an embodiment of bioabsorbable tip 23
constructed of a body 103 with a soft pliable end 104. Body 103 may
be semi-rigid so that bioabsorbable tip 23 is similar to a cotton
swab. Pliable end 104 may be formed of a material that is fibrous,
porous, spongy, etc. Pliable end 104 may provide stability to
bioabsorbable tip 23 within first stage sealing material 67 and may
also provide a liquid seal between bioabsorbable tip 23 and first
stage sealing material 67. As a result, when delivering second
stage sealing material 68, pliable end 104 may prevent second stage
sealing material 68 from entering blood vessel lumen BVL. Pliable
end 104 may also prevent blood from flowing proximally past
bioabsorbable tip 23.
[0131] The sizes of the various embodiments of bioabsorbable tip 23
described above may vary. For example, bioabsorbable tip 23 may be
smaller, larger, or generally the same size as the hollow cavity 90
or other tract formed within first stage sealing material 67.
[0132] Bioabsorbable tip 23 may be positioned in one of a variety
of locations with respect to first and second stage sealing
materials 67, 68. FIGS. 28-31 show exemplary embodiments of
locations of bioabsorbable tip 23 with respect to first and second
stage sealing materials 67, 68.
[0133] FIG. 28 shows an embodiment of bioabsorbable tip 23
positioned within both first stage sealing material 67 and second
stage sealing material 68. Bioabsorbable tip 23 may include a
distal flange 105 and a proximal flange 106. Distal flange 105 may
extend through blood vessel wall BVW and may prevent bioabsorbable
tip 23 from moving proximally. Proximal flange 106 may rest within
first stage sealing material 67, within second stage sealing
material 68, or within both first and second stage sealing
materials 67, 68. Proximal flange 106 may prevent bioabsorbable tip
23 from moving distally or proximally. Both distal and proximal
flanges 105, 106 may also provide a seal between bioabsorbable tip
23 and first and second stage sealing materials 67, 68, e.g., to
prevent second stage sealing material 68 from entering blood vessel
lumen BVL.
[0134] FIG. 29 shows an embodiment of bioabsorbable tip 23
positioned within first stage sealing material 67. In this
embodiment, bioabsorbable tip 23 may include distal flange 105,
which may extend through blood vessel wall BVW and may prevent
bioabsorbable tip 23 from moving proximally.
[0135] FIG. 30 shows an embodiment of bioabsorbable tip 23
positioned within first stage sealing material 67 in close
proximity to blood vessel wall BVW. In this embodiment,
bioabsorbable tip 23 may or may not extend through blood vessel
wall BVW. Bioabsorbable tip 23 may extend at least partially
through a hollow tract formed in first stage sealing material 67.
As shown in FIG. 30, bioabsorbable tip 23 may extend along a distal
portion of the hollow tract in first stage sealing material 67 and
second stage sealing material 68 may be delivered to a proximal
portion of the hollow tract in first stage sealing material 67 so
that a proximal end of bioabsorbable tip 23 may contact second
stage sealing material 68.
[0136] FIG. 31 shows an embodiment of bioabsorbable tip 23 in
contact with first stage sealing material 67 and second stage
sealing material 68. Bioabsorbable tip 23 may extend at least
partially through a hollow tract formed in first stage sealing
material 67. Bioabsorbable tip 23 may extend along a proximal
portion of the hollow tract in first stage sealing material 67 and
a proximal end of bioabsorbable tip 23 may contact second stage
sealing material 68.
[0137] Bioabsorbable tip 23 may connect to temporary sealing
component 11 using one of a variety of attachment and/or release
mechanisms. FIGS. 32-34 show exemplary embodiments of mechanisms
provided to releasably attach bioabsorbable tip 23 to temporary
sealing component 11.
[0138] FIG. 32 shows an embodiment of a mechanism for releasably
attaching bioabsorbable tip 23 to temporary sealing component 11.
Temporary sealing component 11 may include or may be attached to a
structure 107. For example, structure 107 may be a distal end of
wire 27 (FIG. 2) or may be attached to the distal end of wire 27.
As shown in FIG. 32, a distal end of structure 107 may include an
end member 108 having an outer dimension (e.g., width, thickness,
diameter, etc.) that is larger than the corresponding dimension of
structure 107. Bioabsorbable tip 23 may be molded around end member
108 so that bioabsorbable tip 23 includes an inner structure
configured to receive end member 108 when bioabsorbable tip 23 is
attached to structure 107. The geometry of end member 108 and/or
the geometry of the molded inner structure of bioabsorbable tip 23
for receiving end member 108 may be modified to allow bioabsorbable
tip 23 to detach from structure 107 with a desired release force,
e.g., tensile force.
[0139] FIG. 33 shows another embodiment of a mechanism for
releasably attaching bioabsorbable tip 23 to temporary sealing
component 11. Temporary sealing component 11 may include or may be
attached to a structure 109. For example, structure 109 may be a
distal end of wire 27 (FIG. 2) or attached to the distal end of
wire 27. As shown in FIG. 33, a distal end of structure 109 may
include an end member 110 having an outer dimension (e.g., width,
thickness, diameter, etc.) that is larger than the corresponding
dimension of structure 109. Bioabsorbable tip 23 may be molded
around end member 110 so that bioabsorbable tip 23 includes an
inner structure configured to receive end member 110 when
bioabsorbable tip 23 is attached to structure 109. The geometry of
end member 110 and/or the geometry of the molded inner structure of
bioabsorbable tip 23 for receiving end member 110 may be modified
to allow bioabsorbable tip 23 to detach from structure 109 with a
desired release force, e.g., tensile force.
[0140] FIGS. 34 and 35 show a further embodiment of a mechanism for
releasably attaching bioabsorbable tip 23 to temporary sealing
component 11. Temporary sealing component 11 may include or may be
attached to a structure 111. For example, structure 111 may be a
distal end of wire 27 (FIG. 2) or attached to the distal end of
wire 27. As shown in FIGS. 34 and 35, structure 111 may include a
surface that is configured to mate or engage with a corresponding
surface on an end member 113 of bioabsorbable tip 23.
[0141] FIG. 34 shows the corresponding surfaces of structure 111
and end member 113 engaged so that bioabsorbable tip 23 is attached
to temporary sealing component 11. When the corresponding surfaces
are engaged, a tube 114 disposed around wire 27 may slide distally
over the engaged surfaces of structure 111 and end member 113. As a
result, tube 114 may cover and therefore lock the engaged surfaces
of structure 111 and end member 113 together.
[0142] FIG. 35 shows bioabsorbable tip 23 detached from temporary
sealing component 11. To detach bioabsorbable tip 23 from temporary
sealing component 11, tube 114 is pulled back (in the proximal
direction) away from the engaged surfaces of structure 111 and end
member 113. Uncovered, the engaged surfaces of structure 111 and
end member 113 may be separated (e.g., by pulling temporary sealing
component 11 in the proximal direction or otherwise applying a
tensile force), thereby releasing bioabsorbable tip 23 from
temporary sealing component 11.
[0143] Another mechanism for releasably attaching bioabsorbable tip
23 to temporary sealing component 11 may include a member (not
shown) formed of a material capable of breaking when sufficient
tensile force is applied. For example, a member made of a polymer
may attach bioabsorbable tip 23 to temporary sealing component 11,
and the polymer may stretch when tensile force is applied. Necking
may occur in the polymer when tensile force reaches a limit, which
creates a break in the stretched polymer, thereby detaching
bioabsorbable tip 23 from temporary sealing component 11. Tensile
force may be applied when temporary sealing component 11 is pulled
in the proximal direction and bioabsorbable tip 23 is held in place
in first stage sealing material 67 and/or second stage sealing
material 68.
[0144] Other mechanisms for releasably attaching bioabsorbable tip
23 to temporary sealing component 11 may include a cutting
mechanism to cut off bioabsorbable tip 23, a pinching mechanism to
release bioabsorbable tip 23, a pull wire to release bioabsorbable
tip 23, a threaded member to release bioabsorbable tip 23, a
mechanism that applies heat to cause separation of bioabsorbable
tip 23 from temporary sealing component 11, etc. These mechanisms
may be controlled to be able to cut or otherwise detach
bioabsorbable tip 23 from temporary sealing component 11.
[0145] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims.
* * * * *